The analysis of tissue or fluid samples is of crucial importance if the appropriate diagnosis of a patient is to be made by a healthcare worker. Also, there are numerous conditions that need constant monitoring to maintain the correct treatment regime. For example, and not by way of limitation, infectious disease (including HIV), diabetes, osteoporosis, tumor cell markers, reproductive endocrinology, thyroid disease haematology, therapeutic drugs, drugs of abuse, cardiac disease, treatment monitoring clinical trials assessment.
Also, it is apparent that the human genome project will identify genes that are involved, either directly or indirectly, in a number of inherited genetic diseases. Clearly it will be important to efficiently process this genetic information to offer appropriate treatment and/or counseling to individuals that are genetically predisposed to certain diseases. It is highly likely that both conventional processing facilities (i.e., to deal with monitoring various metabolites as described above) and also new means to efficiently process genetic information will be required to deal with expanding healthcare.
It is also apparent that there are situations where adequate medical advice/treatment is either unavailable or not easily accessible to individuals. For example, and not by way of limitation, armed forces personnel on active service in war zones, armed forces personnel on active service in non-war situations but are effectively remote from medical assistance (i.e., ships, submarines, etc.), individuals that farm in remote areas (i.e., Australian Outback, Africa), individuals who work for long periods away from adequate medical assistance (i.e., workers on oil/gas installations, research workers in polar or tropical regions, merchant navy personnel). It is important that these individuals receive rapid and reliable diagnosis of their condition so that the correct treatment is administered.
Also a number of the planet's inhabitants live on remote islands that do not have extensive medical support and may require a rapid means to diagnose a condition that obviates the need for the individual to visit a mainland hospital or alternatively for a doctor to visit the individual on the island to remove samples for analysis.
On a less extreme note there are examples where, although a hospital is local to an individual, there may be extenuating circumstances that prevent or make difficult the attendance of the individual at an outpatient's clinic to give samples for testing. Those suffering, for example, from bronchitis or emphysema, the elderly and infirm and any other individuals who would find a trip to their local hospital physically stressful and potentially hazardous. Currently, patients of this type can have home visits to monitor their condition. However, these are expensive and time consuming since some of a healthcare worker's effective time is spent travelling to the patient's home.
In addition it may be desirable to analyze the recorded result of an assay by a healthcare worker at a data processing site remote from the patient rather than rely on the patient to record and report the result of the test. There are certain patients (i.e., those suffering from mental disorders, e.g., depression, schizophrenia), where it may be desirable to keep the results of an assay secret until the healthcare worker can process the data to enable the correct diagnosis to be determined. It is well known in the art that patients can willfully interfere with an assay to give an erroneous measure of the particular variable monitored by the assay. If the recording device merely records the information for subsequent processing and analysis this possibility is minimized.
This has particular relevance in clinical trial assessment of candidate drugs to provide a non-biased data collection means from treated and placebo groups to ensure a reliable assessment of drug efficacy is obtained. It is therefore an object of the invention to provide a generic assay and a recording device which efficiently monitors an individual's health status. It is a further object of the invention to provide an assay and recording means wherein said recording means is detachable from said assay means.